布洛伪麻胶囊微生物限度检查方法验证试验研究

Study on the Validation Method of Microbial Limit Tests for Buluoweima Capsule

目的建立布洛伪麻胶囊微生物限度检查方法。方法按中国药典2005版微生物限度检查方法进行验证试验。结果试验组枯草芽孢杆菌采用低速离心、培养基稀释法菌回收率为86%以上;大肠埃希菌、金黄色葡萄球菌采用低速离心、平皿法菌回收率为83%以上;黑曲霉、白色念珠菌采用沉降法、培养基稀释法菌回收率为85%以上;控制菌检查试验组采用常规法,可检出大肠埃希菌。结论本法为布洛伪麻胶囊微生物限度检查方法的建立提供依据。

OBJECTIVE To establish a method for determination of microbial limits in Buluoweima capsule. METHODS Validation of microbial limit was tested according to Pharmacopoeia of China 2005 edition. RESULTS The recoveries of bacillus subtilis in test group were above 86% when low speed eentrifugation and diluting method of culture medium were used. The recoveries of escheriehia coll and staphylococcus aureus were above 83% when low speed eentrifugation and plate method were used. The recoveries of aspergillus niger and eandida albieans were above 85% when sedimentation method and diluting method of culture medium were used. Eseheriehia coil can be detected by conventional method. CONCLUSION The proposed method could provide a scientific evidence for establishing a method of microbial limit tests of Buluoleima.